A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma

Fecha de inicio: 16 de abril de 2007

Inclusion Criteria: * Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular retinoblastoma by ophthalmologic examination, defined by the International Classification System for Intraocular Retinoblastoma as the following: * Group C: Discrete localized disease with minimal subretinal and/or vitreous seeding * Subretinal fluid, without prior or concurrent seeding, involving ≤ one quarter of the retina * Local fine vitreous seeding may be present close to discrete tumor * Local subretinal seeding \< 3 mm from tumor * Group D: Diffuse disease with significant vitreous and/or subretinal seeding * Tumor(s) may be massive or diffuse * Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment * Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses * Diffuse subretinal seeding may include subretinal plaques or tumor nodules * Prior enucleation of 1 eye allowed provided the remaining eye is group C or D * No tumor present on histologic examination at the cut end of the optic nerve on any eye enucleated prior to study entry * Evidence of choroidal and/or optic nerve invasion past the lumina cribrosa is allowed * No extraocular retinoblastoma clinically or by MRI of brain and orbits with and without gadolinium or CT scan with and without contrast of brain and orbits * No evidence of systemic metastases by bone marrow, lumbar puncture, bone scan, and/or any other additional test * Performance status - Karnofsky 50-100% (over 16 years of age) * Performance status - Lansky 50-100% (16 and under) * Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age * AST and ALT \< 2.5 times ULN for age * Creatinine adjusted according to age as follows: * No greater than 0.4 mg/dL (≤ 5 months) * No greater than 0.5 mg/dL (6 months -11 months) * No greater than 0.6 mg/dL (1 year-23 months) * No greater than 0.8 mg/dL (2 years-5 years) * No greater than 1.0 mg/dL (6 years-9 years) * No greater than 1.2 mg/dL (10 years-12 years) * No greater than 1.4 mg/dL (13 years and over \[female\]) * No greater than 1.5 mg/dL (13 years to 15 years \[male\]) * No greater than 1.7 mg/dL (16 years and over \[male\]) * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73m\^2 * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test in postmenarchal females * No prior chemotherapy * No other concurrent chemotherapy * No prior radiotherapy * No other concurrent radiotherapy